Trial Outcomes & Findings for Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure (NCT NCT00894387)
NCT ID: NCT00894387
Last Updated: 2013-11-07
Results Overview
Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months of randomization was the primary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 190 (189 days from randomization). The primary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 6 months.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1639 participants
Primary outcome timeframe
6 months
Results posted on
2013-11-07
Participant Flow
Of the 2134 screened patients (including 1 patient who was screened twice), 1639 patients were randomized.
Participant milestones
| Measure |
Aliskiren
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
|
Placebo
Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
|
|---|---|---|
|
Overall Study
STARTED
|
821
|
818
|
|
Overall Study
Safety Set
|
808
|
810
|
|
Overall Study
Full Analysis Set
|
808
|
807
|
|
Overall Study
Completed Primary Efficacy Phase (6 m)
|
717
|
707
|
|
Overall Study
Completed Secondary Efficacy Phase (12m)
|
654
|
640
|
|
Overall Study
COMPLETED
|
646
|
643
|
|
Overall Study
NOT COMPLETED
|
175
|
175
|
Reasons for withdrawal
| Measure |
Aliskiren
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
|
Placebo
Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
|
|---|---|---|
|
Overall Study
Adverse Event
|
44
|
45
|
|
Overall Study
Abnormal Laboratory values
|
2
|
2
|
|
Overall Study
Unsatisfactory therapeutic effect
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Administrative problems
|
2
|
2
|
|
Overall Study
Death
|
77
|
76
|
|
Overall Study
Protocol Deviation
|
4
|
0
|
|
Overall Study
Patient's request
|
25
|
30
|
|
Overall Study
Other (Missing)
|
5
|
3
|
|
Overall Study
Mis-randomized
|
13
|
9
|
|
Overall Study
GCP non-compliance
|
0
|
2
|
Baseline Characteristics
Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure
Baseline characteristics by cohort
| Measure |
Aliskiren
n=808 Participants
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
|
Placebo
n=807 Participants
Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
|
Total
n=1615 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
64.7 years
STANDARD_DEVIATION 12.44 • n=5 Participants
|
64.5 years
STANDARD_DEVIATION 11.88 • n=7 Participants
|
64.6 years
STANDARD_DEVIATION 12.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
171 Participants
n=5 Participants
|
197 Participants
n=7 Participants
|
368 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
637 Participants
n=5 Participants
|
610 Participants
n=7 Participants
|
1247 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Full analysis set (FAS) consisted of randomized patients who had received at least one dose of study drug.
Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months of randomization was the primary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 190 (189 days from randomization). The primary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 6 months.
Outcome measures
| Measure |
Aliskiren
n=808 Participants
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
|
Placebo
n=807 Participants
Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
|
|---|---|---|
|
Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 6 Months
Primary Composite Endpoint
|
201 Participants
|
214 Participants
|
|
Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 6 Months
Cardiovascular death
|
77 Participants
|
85 Participants
|
|
Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 6 Months
Heart faliure re-hospitalization
|
153 Participants
|
166 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Full analysis set (FAS) consisted of randomized patients who had received at least one dose of study drug.
Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 12 months of randomization was the key secondary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 395 (394 days from randomization). The secondary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 12 months.
Outcome measures
| Measure |
Aliskiren
n=808 Participants
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
|
Placebo
n=807 Participants
Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
|
|---|---|---|
|
Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months
Secondary Composite Endpoint
|
283 Participants
|
301 Participants
|
|
Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months
Cardiovascular death
|
126 Participants
|
137 Participants
|
|
Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months
Heart faliure re-hospitalization
|
212 Participants
|
224 Participants
|
SECONDARY outcome
Timeframe: Baseline, 1 months, 6 months and 12 monthsPopulation: Full analysis set included all randomized patients who had taken at least one dose of drug. 'n' in each category indicates patients with assessable data both at baseline and corresponding time points.
Symptom reduction and reduction in physical limitations was assessed using the clinical summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a self-administered questionnaire and contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Health-Related Quality of Life (QoL), including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Each scale score was calculated as the mean of its item scores and transformed to a 0-100 scale, with higher score indicating higher level of functioning. A score of 100 represents perfect health whereas a score of 0 represents death. A positive change in score from baseline indicates an improvement.
Outcome measures
| Measure |
Aliskiren
n=808 Participants
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
|
Placebo
n=807 Participants
Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
|
|---|---|---|
|
Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months
1 Month (n= 574, 571)
|
24.13 units on a scale
Standard Error 0.903
|
23.58 units on a scale
Standard Error 0.908
|
|
Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months
6 Months (n= 485, 474)
|
26.54 units on a scale
Standard Error 1.004
|
24.51 units on a scale
Standard Error 1.016
|
|
Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months
12 Months (n= 241, 230)
|
24.82 units on a scale
Standard Error 1.268
|
24.70 units on a scale
Standard Error 1.291
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Full analysis set included all randomized patients who had taken at least one dose of drug.
A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.
Outcome measures
| Measure |
Aliskiren
n=808 Participants
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
|
Placebo
n=807 Participants
Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
|
|---|---|---|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months
Cardiovascular event
|
209 Participants
|
233 Participants
|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months
Cardiovascular death
|
77 Participants
|
85 Participants
|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months
Heart faliure re-hospitalization
|
153 Participants
|
166 Participants
|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months
All-cause myocardial infarction
|
14 Participants
|
23 Participants
|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months
Fatal myocardial infarction
|
2 Participants
|
6 Participants
|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months
Non-fatal myocardial infarction
|
12 Participants
|
22 Participants
|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months
All-cause stroke
|
13 Participants
|
22 Participants
|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months
Fatal stroke
|
6 Participants
|
4 Participants
|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months
Non-fatal stroke
|
13 Participants
|
22 Participants
|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months
Resuscitated sudden death
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Full ananlysis set included all randomized patients who had at least one dose of study drug.
Outcome measures
| Measure |
Aliskiren
n=808 Participants
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
|
Placebo
n=807 Participants
Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
|
|---|---|---|
|
Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months
|
144 Participants
|
148 Participants
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 6 months and 12 monthsPopulation: Full analysis set included all randomized patients who had taken at least one dose of study drug. 'n' in each category indicates patients with assessable date at baseline and each corresponding time point.
The reported Least square means, and Confidential Interval were from a repeated measures model on log transformed NT-proBNP data containing treatment, visit, and region as factors, log baseline NT-proBNP as a continuous covariate and treatment by visit and visit by log baseline NT-proBNP as interaction terms.
Outcome measures
| Measure |
Aliskiren
n=808 Participants
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
|
Placebo
n=807 Participants
Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
|
|---|---|---|
|
Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months
Month 1 (n= 669, 675)
|
0.86 pg/mL
Interval 0.81 to 0.91
|
0.95 pg/mL
Interval 0.9 to 1.0
|
|
Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months
Month 6 (n= 569, 556)
|
0.64 pg/mL
Interval 0.59 to 0.7
|
0.76 pg/mL
Interval 0.7 to 0.82
|
|
Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months
Month 12 (n=447, 425)
|
0.62 pg/mL
Interval 0.56 to 0.68
|
0.74 pg/mL
Interval 0.67 to 0.82
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Full analysis set included all randomized patients who had taken at least one dose of study drug.
A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.
Outcome measures
| Measure |
Aliskiren
n=808 Participants
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
|
Placebo
n=807 Participants
Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
|
|---|---|---|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months
Cardiovascular event
|
293 Participants
|
321 Participants
|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months
Cardiovascular death
|
126 Participants
|
137 Participants
|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months
Heart faliure re-hospitalization
|
212 Participants
|
224 Participants
|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months
All-cause myocardial infarction
|
18 Participants
|
38 Participants
|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months
Fatal myocardial infarction
|
4 Participants
|
12 Participants
|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months
Non-fatal myocardial infarction
|
16 Participants
|
36 Participants
|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months
All-cause stroke
|
18 Participants
|
27 Participants
|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months
Fatal stroke
|
6 Participants
|
7 Participants
|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months
Non-fatal stroke
|
18 Participants
|
27 Participants
|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months
Resuscitated sudden death
|
5 Participants
|
10 Participants
|
Adverse Events
Aliskiren
Serious events: 421 serious events
Other events: 367 other events
Deaths: 0 deaths
Placebo
Serious events: 435 serious events
Other events: 333 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aliskiren
n=808 participants at risk
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
|
Placebo
n=810 participants at risk
Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.74%
6/808
|
0.62%
5/810
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
0.12%
1/808
|
0.00%
0/810
|
|
Blood and lymphatic system disorders
Hilar lymphadenopathy
|
0.12%
1/808
|
0.00%
0/810
|
|
Blood and lymphatic system disorders
Jaundice acholuric
|
0.00%
0/808
|
0.12%
1/810
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/808
|
0.12%
1/810
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.12%
1/808
|
0.00%
0/810
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.12%
1/808
|
0.00%
0/810
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/808
|
0.12%
1/810
|
|
Cardiac disorders
Acute coronary syndrome
|
0.37%
3/808
|
0.37%
3/810
|
|
Cardiac disorders
Acute left ventricular failure
|
0.12%
1/808
|
0.12%
1/810
|
|
Cardiac disorders
Acute myocardial infarction
|
1.1%
9/808
|
1.9%
15/810
|
|
Cardiac disorders
Angina pectoris
|
1.1%
9/808
|
1.2%
10/810
|
|
Cardiac disorders
Angina unstable
|
0.87%
7/808
|
0.74%
6/810
|
|
Cardiac disorders
Aortic valve incompetence
|
0.12%
1/808
|
0.00%
0/810
|
|
Cardiac disorders
Arrhythmia
|
0.37%
3/808
|
0.37%
3/810
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/808
|
0.12%
1/810
|
|
Cardiac disorders
Arteriospasm coronary
|
0.12%
1/808
|
0.00%
0/810
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
14/808
|
2.0%
16/810
|
|
Cardiac disorders
Atrial flutter
|
0.37%
3/808
|
0.25%
2/810
|
|
Cardiac disorders
Atrial tachycardia
|
0.12%
1/808
|
0.12%
1/810
|
|
Cardiac disorders
Atrioventricular block complete
|
0.25%
2/808
|
0.12%
1/810
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/808
|
0.12%
1/810
|
|
Cardiac disorders
Bradycardia
|
0.12%
1/808
|
0.25%
2/810
|
|
Cardiac disorders
Cardiac arrest
|
1.4%
11/808
|
1.7%
14/810
|
|
Cardiac disorders
Cardiac failure
|
18.2%
147/808
|
19.1%
155/810
|
|
Cardiac disorders
Cardiac failure acute
|
7.2%
58/808
|
7.4%
60/810
|
|
Cardiac disorders
Cardiac failure chronic
|
6.2%
50/808
|
7.7%
62/810
|
|
Cardiac disorders
Cardiac failure congestive
|
2.6%
21/808
|
3.8%
31/810
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/808
|
0.12%
1/810
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.87%
7/808
|
0.37%
3/810
|
|
Cardiac disorders
Cardiogenic shock
|
0.87%
7/808
|
0.74%
6/810
|
|
Cardiac disorders
Cardiomyopathy
|
0.12%
1/808
|
0.00%
0/810
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.25%
2/808
|
0.12%
1/810
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.00%
0/808
|
0.12%
1/810
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.25%
2/808
|
0.25%
2/810
|
|
Cardiac disorders
Coronary artery disease
|
0.50%
4/808
|
0.25%
2/810
|
|
Cardiac disorders
Heart valve incompetence
|
0.00%
0/808
|
0.12%
1/810
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/808
|
0.12%
1/810
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.12%
1/808
|
0.00%
0/810
|
|
Cardiac disorders
Low cardiac output syndrome
|
0.12%
1/808
|
0.00%
0/810
|
|
Cardiac disorders
Myocardial fibrosis
|
0.12%
1/808
|
0.00%
0/810
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
11/808
|
1.4%
11/810
|
|
Cardiac disorders
Myocardial ischaemia
|
0.37%
3/808
|
0.37%
3/810
|
|
Cardiac disorders
Palpitations
|
0.25%
2/808
|
0.25%
2/810
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/808
|
0.12%
1/810
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/808
|
0.25%
2/810
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/808
|
0.12%
1/810
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/808
|
0.25%
2/810
|
|
Cardiac disorders
Tachyarrhythmia
|
0.12%
1/808
|
0.00%
0/810
|
|
Cardiac disorders
Tachycardia
|
0.37%
3/808
|
0.12%
1/810
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.25%
2/808
|
0.49%
4/810
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/808
|
0.12%
1/810
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.12%
1/808
|
0.00%
0/810
|
|
Cardiac disorders
Ventricular fibrillation
|
0.50%
4/808
|
0.62%
5/810
|
|
Cardiac disorders
Ventricular tachycardia
|
1.2%
10/808
|
0.74%
6/810
|
|
Ear and labyrinth disorders
Vertigo
|
0.50%
4/808
|
0.25%
2/810
|
|
Eye disorders
Cataract
|
0.37%
3/808
|
0.00%
0/810
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/808
|
0.12%
1/810
|
|
Eye disorders
Glaucoma
|
0.12%
1/808
|
0.12%
1/810
|
|
Eye disorders
Retinal detachment
|
0.12%
1/808
|
0.00%
0/810
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/808
|
0.12%
1/810
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/808
|
0.12%
1/810
|
|
Gastrointestinal disorders
Abdominal pain
|
0.37%
3/808
|
0.49%
4/810
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/808
|
0.12%
1/810
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/808
|
0.49%
4/810
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/808
|
0.12%
1/810
|
|
Gastrointestinal disorders
Constipation
|
0.25%
2/808
|
0.00%
0/810
|
|
Gastrointestinal disorders
Diarrhoea
|
0.25%
2/808
|
0.37%
3/810
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/808
|
0.12%
1/810
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/808
|
0.12%
1/810
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.12%
1/808
|
0.00%
0/810
|
|
Gastrointestinal disorders
Dyspepsia
|
0.25%
2/808
|
0.25%
2/810
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/808
|
0.12%
1/810
|
|
Gastrointestinal disorders
Enterocolitis
|
0.12%
1/808
|
0.00%
0/810
|
|
Gastrointestinal disorders
Gastritis
|
0.12%
1/808
|
0.00%
0/810
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.12%
1/808
|
0.62%
5/810
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/808
|
0.12%
1/810
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/808
|
0.12%
1/810
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/808
|
0.12%
1/810
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.12%
1/808
|
0.00%
0/810
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.12%
1/808
|
0.12%
1/810
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.12%
1/808
|
0.00%
0/810
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.12%
1/808
|
0.00%
0/810
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/808
|
0.25%
2/810
|
|
Gastrointestinal disorders
Nausea
|
0.99%
8/808
|
0.37%
3/810
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/808
|
0.12%
1/810
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/808
|
0.25%
2/810
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/808
|
0.25%
2/810
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.12%
1/808
|
0.00%
0/810
|
|
Gastrointestinal disorders
Tongue oedema
|
0.00%
0/808
|
0.12%
1/810
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.12%
1/808
|
0.00%
0/810
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.12%
1/808
|
0.00%
0/810
|
|
Gastrointestinal disorders
Vomiting
|
0.62%
5/808
|
0.25%
2/810
|
|
General disorders
Asthenia
|
0.12%
1/808
|
0.37%
3/810
|
|
General disorders
Cardiac death
|
0.37%
3/808
|
0.37%
3/810
|
|
General disorders
Chest discomfort
|
0.12%
1/808
|
0.00%
0/810
|
|
General disorders
Chest pain
|
0.74%
6/808
|
0.00%
0/810
|
|
General disorders
Death
|
2.6%
21/808
|
3.1%
25/810
|
|
General disorders
Device breakage
|
0.00%
0/808
|
0.12%
1/810
|
|
General disorders
Device lead issue
|
0.12%
1/808
|
0.00%
0/810
|
|
General disorders
Device malfunction
|
0.12%
1/808
|
0.49%
4/810
|
|
General disorders
Drug intolerance
|
0.12%
1/808
|
0.00%
0/810
|
|
General disorders
Fatigue
|
0.25%
2/808
|
0.49%
4/810
|
|
General disorders
General physical health deterioration
|
0.25%
2/808
|
0.37%
3/810
|
|
General disorders
Generalised oedema
|
0.25%
2/808
|
0.25%
2/810
|
|
General disorders
Implant site haematoma
|
0.00%
0/808
|
0.12%
1/810
|
|
General disorders
Medical device complication
|
0.00%
0/808
|
0.12%
1/810
|
|
General disorders
Metaplasia
|
0.00%
0/808
|
0.12%
1/810
|
|
General disorders
Multi-organ failure
|
0.12%
1/808
|
0.37%
3/810
|
|
General disorders
Necrosis
|
0.12%
1/808
|
0.00%
0/810
|
|
General disorders
Non-cardiac chest pain
|
0.87%
7/808
|
0.12%
1/810
|
|
General disorders
Oedema peripheral
|
0.37%
3/808
|
0.74%
6/810
|
|
General disorders
Pain
|
0.00%
0/808
|
0.12%
1/810
|
|
General disorders
Pyrexia
|
0.25%
2/808
|
0.25%
2/810
|
|
General disorders
Soft tissue inflammation
|
0.12%
1/808
|
0.00%
0/810
|
|
General disorders
Stent malfunction
|
0.00%
0/808
|
0.12%
1/810
|
|
General disorders
Sudden cardiac death
|
0.62%
5/808
|
0.86%
7/810
|
|
General disorders
Sudden death
|
1.1%
9/808
|
0.62%
5/810
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/808
|
0.12%
1/810
|
|
Hepatobiliary disorders
Cholecystitis
|
0.25%
2/808
|
0.12%
1/810
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.12%
1/808
|
0.25%
2/810
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.12%
1/808
|
0.00%
0/810
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.12%
1/808
|
0.00%
0/810
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/808
|
0.12%
1/810
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.00%
0/808
|
0.12%
1/810
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.12%
1/808
|
0.12%
1/810
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.12%
1/808
|
0.00%
0/810
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/808
|
0.12%
1/810
|
|
Immune system disorders
Heart transplant rejection
|
0.12%
1/808
|
0.00%
0/810
|
|
Infections and infestations
Abscess limb
|
0.00%
0/808
|
0.12%
1/810
|
|
Infections and infestations
Anal abscess
|
0.12%
1/808
|
0.00%
0/810
|
|
Infections and infestations
Appendicitis
|
0.25%
2/808
|
0.00%
0/810
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/808
|
0.12%
1/810
|
|
Infections and infestations
Bacteraemia
|
0.12%
1/808
|
0.12%
1/810
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/808
|
0.12%
1/810
|
|
Infections and infestations
Bronchitis
|
0.74%
6/808
|
0.74%
6/810
|
|
Infections and infestations
Bronchitis bacterial
|
0.12%
1/808
|
0.00%
0/810
|
|
Infections and infestations
Bronchopneumonia
|
0.37%
3/808
|
0.49%
4/810
|
|
Infections and infestations
Cellulitis
|
0.12%
1/808
|
0.37%
3/810
|
|
Infections and infestations
Citrobacter sepsis
|
0.00%
0/808
|
0.12%
1/810
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/808
|
0.12%
1/810
|
|
Infections and infestations
Device related infection
|
0.12%
1/808
|
0.49%
4/810
|
|
Infections and infestations
Endocarditis
|
0.00%
0/808
|
0.37%
3/810
|
|
Infections and infestations
Erysipelas
|
0.25%
2/808
|
0.12%
1/810
|
|
Infections and infestations
Gangrene
|
0.25%
2/808
|
0.37%
3/810
|
|
Infections and infestations
Gastroenteritis
|
0.25%
2/808
|
0.37%
3/810
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.12%
1/808
|
0.12%
1/810
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.12%
1/808
|
0.00%
0/810
|
|
Infections and infestations
Hepatitis B
|
0.12%
1/808
|
0.00%
0/810
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.12%
1/808
|
0.12%
1/810
|
|
Infections and infestations
Influenza
|
0.00%
0/808
|
0.12%
1/810
|
|
Infections and infestations
Liver abscess
|
0.12%
1/808
|
0.00%
0/810
|
|
Infections and infestations
Lobar pneumonia
|
0.12%
1/808
|
0.25%
2/810
|
|
Infections and infestations
Localised infection
|
0.12%
1/808
|
0.00%
0/810
|
|
Infections and infestations
Lower respiratory tract infection
|
0.37%
3/808
|
0.25%
2/810
|
|
Infections and infestations
Lung infection pseudomonal
|
0.00%
0/808
|
0.12%
1/810
|
|
Infections and infestations
Orchitis
|
0.12%
1/808
|
0.00%
0/810
|
|
Infections and infestations
Osteomyelitis
|
0.12%
1/808
|
0.25%
2/810
|
|
Infections and infestations
Osteomyelitis acute
|
0.12%
1/808
|
0.00%
0/810
|
|
Infections and infestations
Paronychia
|
0.12%
1/808
|
0.00%
0/810
|
|
Infections and infestations
Peritonitis
|
0.00%
0/808
|
0.12%
1/810
|
|
Infections and infestations
Pneumonia
|
3.1%
25/808
|
3.3%
27/810
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/808
|
0.12%
1/810
|
|
Infections and infestations
Postoperative wound infection
|
0.12%
1/808
|
0.25%
2/810
|
|
Infections and infestations
Pseudomembranous colitis
|
0.25%
2/808
|
0.00%
0/810
|
|
Infections and infestations
Pseudomonas bronchitis
|
0.00%
0/808
|
0.12%
1/810
|
|
Infections and infestations
Pulmonary sepsis
|
0.12%
1/808
|
0.12%
1/810
|
|
Infections and infestations
Respiratory tract infection
|
0.37%
3/808
|
0.25%
2/810
|
|
Infections and infestations
Sepsis
|
0.99%
8/808
|
0.62%
5/810
|
|
Infections and infestations
Septic shock
|
0.62%
5/808
|
0.62%
5/810
|
|
Infections and infestations
Skin infection
|
0.00%
0/808
|
0.25%
2/810
|
|
Infections and infestations
Staphylococcal sepsis
|
0.12%
1/808
|
0.12%
1/810
|
|
Infections and infestations
Subacute endocarditis
|
0.00%
0/808
|
0.12%
1/810
|
|
Infections and infestations
Upper respiratory tract infection
|
0.12%
1/808
|
0.49%
4/810
|
|
Infections and infestations
Urinary tract infection
|
0.50%
4/808
|
0.62%
5/810
|
|
Infections and infestations
Urosepsis
|
0.00%
0/808
|
0.12%
1/810
|
|
Infections and infestations
Viral infection
|
0.12%
1/808
|
0.00%
0/810
|
|
Infections and infestations
Wound infection pseudomonas
|
0.12%
1/808
|
0.00%
0/810
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.12%
1/808
|
0.00%
0/810
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.12%
1/808
|
0.00%
0/810
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.00%
0/808
|
0.12%
1/810
|
|
Injury, poisoning and procedural complications
Contusion
|
0.12%
1/808
|
0.00%
0/810
|
|
Injury, poisoning and procedural complications
Dermatitis artefacta
|
0.12%
1/808
|
0.00%
0/810
|
|
Injury, poisoning and procedural complications
Electric shock
|
0.12%
1/808
|
0.00%
0/810
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.12%
1/808
|
0.00%
0/810
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/808
|
0.12%
1/810
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/808
|
0.37%
3/810
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.12%
1/808
|
0.00%
0/810
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.50%
4/808
|
0.12%
1/810
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/808
|
0.12%
1/810
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/808
|
0.12%
1/810
|
|
Injury, poisoning and procedural complications
Head injury
|
0.12%
1/808
|
0.00%
0/810
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.12%
1/808
|
0.25%
2/810
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.25%
2/808
|
0.12%
1/810
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
0.00%
0/808
|
0.12%
1/810
|
|
Injury, poisoning and procedural complications
Laceration
|
0.12%
1/808
|
0.00%
0/810
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/808
|
0.12%
1/810
|
|
Injury, poisoning and procedural complications
Optic nerve injury
|
0.00%
0/808
|
0.12%
1/810
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.12%
1/808
|
0.12%
1/810
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/808
|
0.12%
1/810
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.12%
1/808
|
0.00%
0/810
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.12%
1/808
|
0.00%
0/810
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.12%
1/808
|
0.00%
0/810
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/808
|
0.12%
1/810
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/808
|
0.12%
1/810
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.12%
1/808
|
0.00%
0/810
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.12%
1/808
|
0.00%
0/810
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.12%
1/808
|
0.12%
1/810
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.25%
2/808
|
0.00%
0/810
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.12%
1/808
|
0.00%
0/810
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/808
|
0.12%
1/810
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.25%
2/808
|
0.12%
1/810
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/808
|
0.12%
1/810
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/808
|
0.25%
2/810
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.00%
0/808
|
0.12%
1/810
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.00%
0/808
|
0.12%
1/810
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/808
|
0.12%
1/810
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.12%
1/808
|
0.12%
1/810
|
|
Investigations
Blood creatinine increased
|
0.37%
3/808
|
0.12%
1/810
|
|
Investigations
Blood osmolarity decreased
|
0.00%
0/808
|
0.12%
1/810
|
|
Investigations
Blood potassium increased
|
0.00%
0/808
|
0.12%
1/810
|
|
Investigations
Coagulation test abnormal
|
0.00%
0/808
|
0.12%
1/810
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/808
|
0.12%
1/810
|
|
Investigations
Haemoglobin decreased
|
0.12%
1/808
|
0.00%
0/810
|
|
Investigations
International normalised ratio increased
|
0.25%
2/808
|
0.12%
1/810
|
|
Investigations
Renal function test abnormal
|
0.12%
1/808
|
0.00%
0/810
|
|
Investigations
Transaminases increased
|
0.00%
0/808
|
0.12%
1/810
|
|
Investigations
Urine output decreased
|
0.00%
0/808
|
0.37%
3/810
|
|
Investigations
Weight increased
|
0.12%
1/808
|
0.37%
3/810
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.12%
1/808
|
0.00%
0/810
|
|
Metabolism and nutrition disorders
Dehydration
|
0.37%
3/808
|
0.49%
4/810
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.12%
1/808
|
0.37%
3/810
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.37%
3/808
|
0.37%
3/810
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.12%
1/808
|
0.00%
0/810
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/808
|
0.12%
1/810
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.12%
1/808
|
0.00%
0/810
|
|
Metabolism and nutrition disorders
Fluid intake reduced
|
0.12%
1/808
|
0.00%
0/810
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.12%
1/808
|
0.12%
1/810
|
|
Metabolism and nutrition disorders
Gout
|
0.25%
2/808
|
0.37%
3/810
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.25%
2/808
|
0.37%
3/810
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.5%
12/808
|
1.5%
12/810
|
|
Metabolism and nutrition disorders
Hyperosmolar state
|
0.00%
0/808
|
0.12%
1/810
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/808
|
0.12%
1/810
|
|
Metabolism and nutrition disorders
Hypocholesterolaemia
|
0.00%
0/808
|
0.12%
1/810
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.87%
7/808
|
0.25%
2/810
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.74%
6/808
|
0.74%
6/810
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.50%
4/808
|
0.62%
5/810
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/808
|
0.12%
1/810
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/808
|
0.12%
1/810
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.12%
1/808
|
0.00%
0/810
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.12%
1/808
|
0.00%
0/810
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.12%
1/808
|
0.25%
2/810
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.12%
1/808
|
0.00%
0/810
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.12%
1/808
|
0.00%
0/810
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.00%
0/808
|
0.12%
1/810
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.12%
1/808
|
0.12%
1/810
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/808
|
0.12%
1/810
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.12%
1/808
|
0.00%
0/810
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/808
|
0.12%
1/810
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.12%
1/808
|
0.00%
0/810
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.25%
2/808
|
0.25%
2/810
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.25%
2/808
|
0.12%
1/810
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/808
|
0.12%
1/810
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.12%
1/808
|
0.12%
1/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign bone neoplasm
|
0.00%
0/808
|
0.12%
1/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.12%
1/808
|
0.00%
0/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/808
|
0.12%
1/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma
|
0.00%
0/808
|
0.12%
1/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.12%
1/808
|
0.12%
1/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.25%
2/808
|
0.12%
1/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.12%
1/808
|
0.00%
0/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.12%
1/808
|
0.00%
0/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatobiliary neoplasm
|
0.12%
1/808
|
0.00%
0/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/808
|
0.12%
1/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.00%
0/808
|
0.12%
1/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.12%
1/808
|
0.00%
0/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.12%
1/808
|
0.00%
0/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.12%
1/808
|
0.00%
0/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.12%
1/808
|
0.00%
0/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/808
|
0.12%
1/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal neoplasm
|
0.00%
0/808
|
0.12%
1/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/808
|
0.12%
1/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.12%
1/808
|
0.37%
3/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.12%
1/808
|
0.00%
0/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.12%
1/808
|
0.12%
1/810
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.12%
1/808
|
0.00%
0/810
|
|
Nervous system disorders
Anterior spinal artery syndrome
|
0.12%
1/808
|
0.00%
0/810
|
|
Nervous system disorders
Aphasia
|
0.00%
0/808
|
0.12%
1/810
|
|
Nervous system disorders
Burning sensation
|
0.12%
1/808
|
0.00%
0/810
|
|
Nervous system disorders
Cerebellar infarction
|
0.12%
1/808
|
0.12%
1/810
|
|
Nervous system disorders
Cerebral haematoma
|
0.12%
1/808
|
0.00%
0/810
|
|
Nervous system disorders
Cerebral infarction
|
0.12%
1/808
|
0.12%
1/810
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/808
|
0.12%
1/810
|
|
Nervous system disorders
Cerebrovascular accident
|
1.1%
9/808
|
1.9%
15/810
|
|
Nervous system disorders
Coma
|
0.12%
1/808
|
0.00%
0/810
|
|
Nervous system disorders
Convulsion
|
0.00%
0/808
|
0.12%
1/810
|
|
Nervous system disorders
Diabetic hyperglycaemic coma
|
0.00%
0/808
|
0.12%
1/810
|
|
Nervous system disorders
Diabetic neuropathy
|
0.12%
1/808
|
0.00%
0/810
|
|
Nervous system disorders
Dizziness
|
0.50%
4/808
|
0.00%
0/810
|
|
Nervous system disorders
Dysarthria
|
0.12%
1/808
|
0.00%
0/810
|
|
Nervous system disorders
Embolic stroke
|
0.25%
2/808
|
0.00%
0/810
|
|
Nervous system disorders
Epilepsy
|
0.25%
2/808
|
0.00%
0/810
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.12%
1/808
|
0.00%
0/810
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/808
|
0.37%
3/810
|
|
Nervous system disorders
Hypokinesia
|
0.12%
1/808
|
0.12%
1/810
|
|
Nervous system disorders
Intracranial haematoma
|
0.12%
1/808
|
0.00%
0/810
|
|
Nervous system disorders
Ischaemic stroke
|
0.62%
5/808
|
1.1%
9/810
|
|
Nervous system disorders
Loss of consciousness
|
0.12%
1/808
|
0.00%
0/810
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.12%
1/808
|
0.00%
0/810
|
|
Nervous system disorders
Myasthenia gravis
|
0.12%
1/808
|
0.00%
0/810
|
|
Nervous system disorders
Myasthenia gravis crisis
|
0.12%
1/808
|
0.00%
0/810
|
|
Nervous system disorders
Neuropathy peripheral
|
0.12%
1/808
|
0.00%
0/810
|
|
Nervous system disorders
Presyncope
|
0.37%
3/808
|
0.49%
4/810
|
|
Nervous system disorders
Sensory disturbance
|
0.12%
1/808
|
0.12%
1/810
|
|
Nervous system disorders
Somnolence
|
0.25%
2/808
|
0.12%
1/810
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/808
|
0.25%
2/810
|
|
Nervous system disorders
Syncope
|
1.4%
11/808
|
1.6%
13/810
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/808
|
0.37%
3/810
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.12%
1/808
|
0.00%
0/810
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.12%
1/808
|
0.00%
0/810
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.12%
1/808
|
0.00%
0/810
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/808
|
0.12%
1/810
|
|
Psychiatric disorders
Abnormal behaviour
|
0.12%
1/808
|
0.00%
0/810
|
|
Psychiatric disorders
Alcohol abuse
|
0.12%
1/808
|
0.00%
0/810
|
|
Psychiatric disorders
Anxiety
|
0.12%
1/808
|
0.00%
0/810
|
|
Psychiatric disorders
Confusional state
|
0.25%
2/808
|
0.00%
0/810
|
|
Psychiatric disorders
Depression
|
0.12%
1/808
|
0.12%
1/810
|
|
Psychiatric disorders
Depression suicidal
|
0.12%
1/808
|
0.00%
0/810
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/808
|
0.12%
1/810
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/808
|
0.12%
1/810
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/808
|
0.12%
1/810
|
|
Psychiatric disorders
Restlessness
|
0.12%
1/808
|
0.12%
1/810
|
|
Psychiatric disorders
Screaming
|
0.12%
1/808
|
0.00%
0/810
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/808
|
0.12%
1/810
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.12%
1/808
|
0.12%
1/810
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/808
|
0.12%
1/810
|
|
Renal and urinary disorders
Bladder tamponade
|
0.12%
1/808
|
0.00%
0/810
|
|
Renal and urinary disorders
Haematuria
|
0.12%
1/808
|
0.00%
0/810
|
|
Renal and urinary disorders
Nephropathy
|
0.12%
1/808
|
0.00%
0/810
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/808
|
0.12%
1/810
|
|
Renal and urinary disorders
Polyuria
|
0.12%
1/808
|
0.00%
0/810
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.12%
1/808
|
0.00%
0/810
|
|
Renal and urinary disorders
Renal artery thrombosis
|
0.00%
0/808
|
0.12%
1/810
|
|
Renal and urinary disorders
Renal failure
|
0.74%
6/808
|
0.99%
8/810
|
|
Renal and urinary disorders
Renal failure acute
|
2.5%
20/808
|
1.5%
12/810
|
|
Renal and urinary disorders
Renal failure chronic
|
0.12%
1/808
|
0.37%
3/810
|
|
Renal and urinary disorders
Renal impairment
|
0.62%
5/808
|
0.49%
4/810
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/808
|
0.12%
1/810
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.25%
2/808
|
0.00%
0/810
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.12%
1/808
|
0.00%
0/810
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/808
|
0.12%
1/810
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/808
|
0.12%
1/810
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.87%
7/808
|
0.49%
4/810
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.12%
1/808
|
0.00%
0/810
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.25%
2/808
|
0.12%
1/810
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.12%
1/808
|
0.00%
0/810
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.12%
1/808
|
0.00%
0/810
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.12%
1/808
|
0.00%
0/810
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/808
|
0.12%
1/810
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/808
|
0.12%
1/810
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.6%
13/808
|
0.62%
5/810
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.25%
2/808
|
0.25%
2/810
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
20/808
|
2.2%
18/810
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/808
|
0.12%
1/810
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea paroxysmal nocturnal
|
0.00%
0/808
|
0.12%
1/810
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/808
|
0.25%
2/810
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.12%
1/808
|
0.37%
3/810
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/808
|
0.12%
1/810
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/808
|
0.12%
1/810
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/808
|
0.12%
1/810
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.25%
2/808
|
0.25%
2/810
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/808
|
0.12%
1/810
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.12%
1/808
|
0.00%
0/810
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.12%
1/808
|
0.00%
0/810
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.12%
1/808
|
0.00%
0/810
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.12%
1/808
|
0.00%
0/810
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.12%
1/808
|
0.25%
2/810
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.62%
5/808
|
0.62%
5/810
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.50%
4/808
|
0.99%
8/810
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/808
|
0.12%
1/810
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/808
|
0.12%
1/810
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/808
|
0.12%
1/810
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.74%
6/808
|
0.62%
5/810
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.12%
1/808
|
0.00%
0/810
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/808
|
0.12%
1/810
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.12%
1/808
|
0.25%
2/810
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.25%
2/808
|
0.00%
0/810
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/808
|
0.12%
1/810
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.12%
1/808
|
0.12%
1/810
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.12%
1/808
|
0.00%
0/810
|
|
Skin and subcutaneous tissue disorders
Skin ulcer haemorrhage
|
0.12%
1/808
|
0.00%
0/810
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/808
|
0.12%
1/810
|
|
Surgical and medical procedures
Gastric bypass
|
0.00%
0/808
|
0.12%
1/810
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/808
|
0.25%
2/810
|
|
Vascular disorders
Deep vein thrombosis
|
0.12%
1/808
|
0.12%
1/810
|
|
Vascular disorders
Extremity necrosis
|
0.12%
1/808
|
0.00%
0/810
|
|
Vascular disorders
Haematoma
|
0.12%
1/808
|
0.12%
1/810
|
|
Vascular disorders
Hypertension
|
0.25%
2/808
|
0.37%
3/810
|
|
Vascular disorders
Hypertensive crisis
|
0.12%
1/808
|
0.37%
3/810
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/808
|
0.25%
2/810
|
|
Vascular disorders
Hypotension
|
3.0%
24/808
|
2.0%
16/810
|
|
Vascular disorders
Intra-abdominal haematoma
|
0.00%
0/808
|
0.12%
1/810
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/808
|
0.25%
2/810
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.50%
4/808
|
0.25%
2/810
|
|
Vascular disorders
Peripheral ischaemia
|
0.12%
1/808
|
0.00%
0/810
|
|
Vascular disorders
Peripheral vascular disorder
|
0.25%
2/808
|
0.12%
1/810
|
|
Vascular disorders
Phlebitis
|
0.12%
1/808
|
0.00%
0/810
|
|
Vascular disorders
Venous haemorrhage
|
0.00%
0/808
|
0.12%
1/810
|
Other adverse events
| Measure |
Aliskiren
n=808 participants at risk
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
|
Placebo
n=810 participants at risk
Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.1%
49/808
|
4.4%
36/810
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
19.2%
155/808
|
15.8%
128/810
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.2%
42/808
|
6.5%
53/810
|
|
Nervous system disorders
Dizziness
|
4.3%
35/808
|
5.3%
43/810
|
|
Renal and urinary disorders
Renal impairment
|
5.8%
47/808
|
4.1%
33/810
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.3%
59/808
|
6.5%
53/810
|
|
Vascular disorders
Hypotension
|
14.5%
117/808
|
10.2%
83/810
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER